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Can antibodies flush out hidden HIV? new trial aims to find out

NCT ID NCT05612178

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 21, 2026 · Updated 1 time

Summary

This study tests whether two lab-made antibodies, 3BNC117-LS and 10-1074-LS, can safely reduce the hidden HIV reservoir in people already on suppressive antiretroviral therapy (ART). The trial involves 105 adults with HIV who will receive three infusions of the antibodies or a placebo over 40 weeks. Researchers will monitor side effects and measure changes in the number of HIV-infected cells to see if the antibodies can help control the virus long-term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
3BNC117-LS and 10-1074-LS (antibodies)
What this could lead to
If successful, this could point toward a way to shrink the hidden HIV reservoir, potentially allowing people with HIV to control the virus without daily medication.
What could go wrong
This is an early phase 1 trial focused on safety, so it may not show a meaningful reduction in the reservoir. The antibodies are given alongside standard ART, and any benefit is uncertain at this stage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

105 people

The number who actually took part.

Started

Jul 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Ability to provide informed consent; 2. Stated willingness to comply with all study procedures and availability for the duration of the study; 3. Adult persons of any sex or gender, aged 18 years to 70; 4. Confirmed HIV-1 infection and clinically stable; 5. On antiretroviral therapy with plasma HIV-1 RNA levels of \< 50 copies/mL and no reported interruption of ART for 7 consecutive days or longer for at least 96 weeks. NOTE: At least two viral load (VL) measurements within 48 weeks prior to the screening visit must be available for review. A single plasma HIV-1 RNA \> 50 copies/mL but \< 200 copies/mL over 48 weeks that is followed by an HIV-1 RNA \< 50 copies/mL is permitted; 6. Current CD4+ T cell counts \> 300 cells/mcL; 7. For participants who can become pregnant (i.e., participants who have not been postmenopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), must have a negative pregnancy test at screening and within 48 hours prior to day 0; NOTE: Participant-reported history is acceptable as documentation of hysterectomy and bilateral oophorectomy, tubal ligation, tubal micro-inserts, and vasectomy. 8. Participants who can become pregnant must agree to use adequate measures to prevent pregnancy. This includes the use an effective method of contraception for the study duration. Contraception must be used from 10 days prior to the first dose of the investigational products (IPs), while receiving the IPs and during study follow up. Acceptable methods of contraception include: * Contraceptive subdermal implant * Intrauterine device or intrauterine system * Combined estrogen and progestogen oral contraceptive * Injectable progestogen * Contraceptive vaginal ring * Percutaneous contraceptive patches NOTE: Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant, will be allowed. The documentation of partner sterility can come from the site personnel s review of medical records, medical examination and/or semen analysis, or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents. 9. Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to the first dose of the IPs, while receiving the IPs and during study follow up to avoid impregnating a partner who can get pregnant. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of AIDS-defining illness within 3 years prior to enrollment; 2. History of systemic corticosteroids (e.g., an equivalent dose of prednisone of \> 20 mg daily for \>14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months; 3. Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis, active malignancy that may require systemic chemotherapy or radiation therapy), other than HIV infection, that in the opinion of the investigator would preclude participation; 4. Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood. NOTE: Participants with a positive test for HCV antibody and a negative test for HCV RNA are eligible; 5. Participants with known hypersensitivity to any constituent of the investigational products; 6. Pregnancy or lactation; 7. ART initiated during acute infection (defined as p24, HIV nucleic acid amplification technique \[NAAT\], or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing); 8. Laboratory abnormalities in the parameters listed below: * Absolute neutrophil count \< 1,000 cells/microliter * Hemoglobin \< 10 gm/dL * Platelet count \< 100,000 cells/microliter * ALT \> 1.5 x ULN * AST \> 1.5 x ULN * Total bilirubin \> 1.5 x ULN * Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m\^2 9. Any history of receipt of HIV-1 mAb therapy or HIV vaccine; 10. Participation in any clinical study of an investigational product within 12 weeks prior to study entry (day 0) or expected participation in such a study during this study; 11. Any approved or experimental non-HIV vaccination (e.g., SARS-CoV-2, hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment (day 0); 12. Inability to undergo leukapheresis due to poor venous access or other medical conditions; 13. Active drug or alcohol use or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892, United States

  • The Rockefeller University

    New York, New York, 10065, United States

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Other studies related to the condition(s) this trial covers.